The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval of the premarket approval application for Ocular’s ReSure product.
The company said it plans to respond to the agency within the mandated 15-day period.
“Ocular Therapeutix takes the warning letter seriously and is committed to working with the FDA to address and resolve the concerns cited in the warning letter,” the company wrote.
Ocular’s ReSure Sealant is indicated for the intraoperative management of clear corneal incisions with a demonstrated wound leak for which a temporary dry surface can be achieved. The product is designed to prevent post-operative fluid egress from such incisions in adults who have had cataract surgery.
OCUL shares fell to $6.00 apiece in premarket activity today, down -2.9%.